Obesity and gastroesophageal reflux disease (GERD) both impact a substantial number of people in society. Therapies exist to treat these diseases; however, many of the current therapies have limitations that result in only a sub segment of the market receiving treatment. Spurred by the continuing growth of these diseases, new therapies are being developed to address these limitations.
Current therapies for obesity range in invasiveness and efficacy. The least invasive therapies include diet, exercise, and pharmaceuticals. These therapies have not yet shown significant weight loss over the long-term. More invasive treatment options include weight loss surgeries, such as gastric bypass, vertical banded gastroplasty, and adjustable gastric banding. These procedures share at least one common element, namely, restricting stomach size. These procedures have shown long-term weight loss, but carry significant surgery-associated risks.
New devices are being developed to achieve the efficacy of weight loss surgery, while employing less invasive procedures. These devices utilize mechanisms of action that include restricting stomach size, stimulating the stomach (e.g., using electrical stimulation), filling a portion of the stomach with a space-occupying member, and introducing one or more malabsorptive elements into the stomach. While the invasiveness of the weight loss procedures has been reduced, the new mechanisms of action remain to be clinically proven. Additionally, many of the new weight loss devices are large and bulky, which reduces ease of use and may lead to long procedure times.
In addition, treatment of GERD follows a progression of therapies. Initially, lifestyle modifications, which include changes to diet, are utilized. If symptoms persist, the next level of treatment is typically pharmacologic therapies, which range from antacids to proton pump inhibitors. These therapies tend to be tolerated over the long-term. For more severe cases of GERD, or for cases where patients seek a one-time treatment, surgery may be required. The most common surgical procedure is fundoplication, which has good efficacy but carries the inherent risks of surgery.
Similar to new obesity treatments, new GERD treatments seek to obtain the efficacy of surgery but in a less invasive manner. These therapies seek to reduce the esophageal aperture via mechanisms of action including radio frequency ablation, esophageal cinching, and tissue plication.
Due to the great need in the areas of obesity and GERD, the development of additional less invasive device solutions is desirable.